K253740
- 510(k) number
- K253740
- Device name
- TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
- Applicant
- Hong Qiangxing (Shenzhen) Electronics Limited CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2025-12-23
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K253740
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.